“…Regulatory challenges occur at several levels, namely, harmonization of law, fair trade practice, population exposures to chemicals and contaminants, food borne illness, rise in NCD's, novel ingredients, new technologies and a legacy of regulatory practice. …”
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“…Toward clinical implementation, a more comprehensive understanding of NfL concentrations in disease subtypes with overlapping phenotypes and at defined stages of disease, and the development of a harmonization program, are warranted.…”
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“…Therefore, data standardization and validation within datasets, harmonization across datasets, and application of appropriate analysis methods are important considerations. …”
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“…In 2005, the International Council for Harmonization (ICH) established cardiotoxicity assessment guidelines to identify the risk of Torsade de Pointes (TdP). …”
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“…The new method was then validated following International Conference on Harmonization (ICH) guidance. The method shows a good linearity with r(2) > 0.99. …”
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“…Future challenges were identified and included the need of whole-chain assessments, centralization of data collection processes, and improvement of model interoperability through harmonization. The present analysis can serve as a source of data and information to inform QMRA framework for beef meat and will help the scientific community and food safety authorities to identify specific monitoring and research needs.…”
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“…Individual treatment approach includes the harmonization of CML disease characteristics, clinical experience, and best available clinical evidence. …”
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“…However, unwanted or uncontrollable effects originating from unexpected thermodynamic perturbations or complex cooperative interactions interfere at the molecular level with the designed assembly process. Correction and harmonization of unwanted processes is one of the major challenges of the next decades and requires a deeper knowledge and understanding of the key factors that drive the formation of nanomaterials. …”
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“…A concise list includes: (a) successful harmonization of intra/inter-modality radiomic measurements to facilitate the association with other data domains (genetic, clinical, lifestyle aspects, etc.); (b) ability of data science to revise model strategies and analytics tools to tackle multiple data types and structures (electronic medical records, personal histories, hospitalization data, genomic from various specimens, imaging, etc.) and to offer data-agnostic solutions for patient outcomes prediction; (c) and model validation with independent datasets to ensure generalization of results, clinical value of new risk stratifications, and support to clinical decisions for highly individualized patient management.…”
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“…To achieve this, EASOM proposes to promote OH education and training of MDs at undergraduate and postgraduate levels, foster harmonization of OH education and teaching standards and programs across EU countries, and enhance cooperation between universities and international scientific associations. …”
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“…In this meeting, we aimed to find consensus on ongoing issues of quality control (QC), safety, and efficacy of human pluripotent stem cell banks and their derivative cell therapy products for the global harmonization. In particular, assays for the QC testing such as pluripotency assays test and general QC testing criteria were intensively discussed. …”
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“…The complete protocol of the newly developed M. cynos tuf assay is provided to facilitate assay harmonization.…”
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“…However, despite the efforts to build reliable data, some CRMs such as cobalt, are still characterised by lack of data harmonization, lack of connection between datasets, and significant data unavailability. …”
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“…Stability tests, according to the International Conference on Harmonization rules, were applied on ethanol solutions and topical gel formulations of both compounds. …”
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“…Before extraction, a harmonization of signs and symptoms of mania and depression was performed in order to reduce the variability between individual studies. …”
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“…Consequently, procedures for SF laboratory testing are poorly harmonized. This document is the second in the series of recommendations prepared by the members of the Working group for extravascular body fluid samples of the Croatian Society of Medical Biochemistry and Laboratory Medicine. …”
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“…International Conference on Harmonization validation guidelines were followed to fully validate the method, and linearity was obtained for the two drugs over the range of 0.1–0.7 µg ml(−1) for terbinafine and 0.5–4.0 µg ml(−1) for itraconazole. …”
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“…However, the appropriate timing for a harmonized guidance, particularly with a platform that continues to rapidly evolve, remains in question.…”
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“…We finally review important concepts of harmonization and curation of high throughput datasets, and we discuss the potential of systems biomedicine to derive and evaluate RNA biomarker signatures from high-throughput expression data.…”
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“…The method was validated according to the guidelines of the US Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and Eurachem with respect to system suitability, linearity, accuracy, precision, recovery, limits of detection and quantification, ruggedness, selectivity and specificity. …”
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